JP2011530357A - Connector for disposable containers to be used in dialysis machines - Google Patents

Abstract

  The present invention is a connector for a replaceable container to be used in a medical instrument, comprising at least a body, wherein an inlet tube and an outlet tube are provided across the inner part of the body, the inlet tube and the outlet tube being Extending from the inside of such a container towards the outer part of the connector, the inlet tube and the outlet tube extending separately to two laterally spaced holes, which are connected to the medical instrument The connector is characterized in that it can be removably attached to the attachment means and the supplemental connection.

Description

  Hemodialysis machines utilize one or several salt concentrate aqueous solutions, such as sodium bicarbonate solution, to purify the patient's blood under dialysis treatment, thus acting as a kind of artificial kidney. This concentrate can be obtained from a powdered or granular salt compound provided by a hemodialysis machine in a disposable replaceable container, which can be of the bag type. In a standard process, water is provided by a hemodialysis machine to dissolve, for example, powdered sodium bicarbonate, and a usable solution is simultaneously removed from the container through a separate tube.

  The present invention relates to a connector disposed in a container, useful for attaching the container to a dialysis machine, and formed by a water inlet and a solution outlet.

  EP 1 344 550 describes a connector for the same purpose, which is made in one piece with three tubes. The main tube is a central bore that completely traverses the member between its outer and inner parts (the member is thus constructed, since this member has a connector corresponding to such a container. The central bore is used to fill the container with a soluble solid powder or granular salt, thus the diameter of the central bore is Is big. The other two tubes are each designed for water inflow and solution outflow, each of which has a length parallel to the central tube from the inner part of the connector to the vicinity of the outer part. From the vicinity of the outer part, the tube extends outward and extends in a parallel direction along each side wing or along the edge of the outer part and is configured to be plugged into a dialysis instrument. It has reached the part. FIGS. 4 and 5 of this European Patent Application show the general features of the above-described dialyzer model mounting console, with the side tube following a path that forms two or more bends. It is shown in the state and therefore, for mold design purposes, if the member is made of plastic, an open side tube can be provided on the outer side by molding.

  The pre-fill operation is typically performed during the container manufacturing process itself, and a pre-fill operation may be followed by a sealing operation in which the flexible sheet is placed on the outside of the connector. As can be seen in FIG. 2 of the above-mentioned European Patent Application 1,344,550, the contents are lost over the mouth of the central tube and are contaminated in the container. To avoid both. These procedures are performed in the sterilization area. The same sheet also covers the side tube provided with openings by molding as shown in FIG. 1 of such European Patent Application.

  Argentine Patent Application No. 37,133 relates to a connecting cap for a double component bag used in the hemodialysis machine described above. FIGS. 3, 4 and 5 of such Argentine Patent Application 37,133 comprise two inlet and outlet tubes made of an assembly of two sealed and mated members. The connector is shown. One member is annular in shape and is introduced into a replaceable bag so that the inner portion of each tube is in fluid communication with a separate compartment. The second central member is not disposed within the annular member until immediately after the bag is pre-filled with the powdered product through the large diameter central tube. The central member includes a disk that seals the central tube once it is snapped into the annular member, thus the connector that attaches the bag to the dialysis instrument when the dialysis instrument opens as a valve that allows water to flow in and dissolve the product. And the dialysis machine removes the resulting solution through a tube.

  Finally, FIGS. 2 and 3 of Arg 35,471 show a two-part molded connector with ribs to allow assembly.

European Patent Application Publication No. 1,344,550 Argentine Patent Application Publication No. 37,133

  The object of the present invention is to develop a novel connector for use in a replaceable container of the type as described in Argentine Patent Application 35,471.

  Another object of the present invention is to eliminate the opening sealing procedure for the outer part of the connector with a welded sheet or film performed as described in the above-mentioned US patent specification. Another object is to provide a connector structure with a novel sealing system that is effective for one-compartment or two-compartment disposable containers.

  Another problem to be solved by the present invention is to achieve a safe and cost effective way of sealing an open channel or groove formed by a tube around the outside of the connector wing.

  These problems are solved by the connector according to claim 1, the replaceable disposable container according to claim 11, the method for manufacturing the connector according to claim 14, and the method for manufacturing the replaceable instrument according to claim 16. Variations of the invention are the subject matter of the dependent claims.

  The above advantages, objects and solutions and other advantages, objects and solutions that will become apparent from the following description are, in one embodiment, attached to the connector body itself by a flexible or hinged or fragile linkage. This is achieved by constructing a connector with a cap. In another operation, the cap is folded along the outside and hermetically closed to close the tube opening in the side wing of the tube.

  In a preferred embodiment, the connector has a member, preferably an annular member, disposed in the bag opening, which member is configured as disclosed in Argentine Patent Application No. 35,471. The solid product pre-filling operation is carried out through this member, and the connector further comprises a central member constituting a nozzle with the essential features of the connector described in the above paragraph.

  Reference is made to Argentine Patent Application Publication No. 35,471 and European Patent Application Publication No. 1,344,550 (A1), the entire contents of which are incorporated herein by reference.

  In order to facilitate an understanding of the content of the invention and the manner in which it can be practiced, a detailed description of a preferred embodiment of the invention is provided below with reference to the example drawings attached hereto. The accompanying drawings are given by way of illustration and not as limitations of the invention, and the components of the invention will be understood by those skilled in the art from various equivalents without departing from the principles of the invention. Selected from example.

1 is an exploded perspective view of a single-compartment disposable dialysis bag having a connector as a preferred embodiment of the present invention. FIG. FIG. 2 is a top perspective view of the connector shown in FIG. 1 with the squeezable cap initially open to expose the solvent inlet port and the solution outlet port. FIG. 3 is a perspective view similar to FIG. 2, but with the connector shown with the squeezable cap closed, and an inlet port and an outlet port provided on all of the extensions continuous to the outer part of the connector as a part It is a figure which shows the state by which was sealed. It is the perspective view seen from the front lower side of the connector shown by FIG. 1 with shape | molding. It is the perspective view which looked at the connector shown by FIG. 4 from back lower direction. FIG. 3 is a perspective view from below of the connector shown in FIG. 2, showing the state where the connection port is now sealed. FIG. 7 is a rear perspective view of the connector shown in FIG. 6. FIG. 8 is a view of the member sealingly attached to the connector as shown in FIGS. 6 and 7.

  Referring to FIG. 1, first, an elongate single compartment bag 11 made of two sheet (plate) -like walls (hereinafter sometimes referred to as “wall sheets”) is shown. One is provided with an opening 13 and a connector 15 is shown unattached for illustrative purposes. In order to place the connector member 15 in the bag, an auxiliary member 17 (in this embodiment, this member is of an annular shape) is positioned at the rim of the opening 13 and this annular member is The connector body 15 can be received within the throat or opening 13 in a centered manner, thus creating a sealed fit.

  As shown in FIG. 2, the member 15 has a central body 19 which has an annular rib 21 and two wing-like lateral sides that can be securely held in the opening 13 of the annular member 17. There are extensions 23 in which pipes or conduits 25 extend for injecting water and for taking out solutions, respectively. These conduits 25 extend from corresponding holes 27 in the wing end 23 that are configured to allow attachment and connection to a dialysis machine (not shown), one end of which is a member. It has a somewhat possible length to form an open channel 29 at the outer or rear side 31 and then leads to the inner part 33 of the connector, the solution outlet pipe being used for the attachment of the suction pipe 35 The distal end of the suction tube ends with a filter 37, so that in use, the filter 37 is located at the bottom end of the bag 11 at the opposite end of the opening 13. It is supposed to be. Similarly, the inlet pipe for injecting water may have a filter element whose end is located directly in the central body 19. This filter element can be manufactured by various manufacturing techniques. In one embodiment, the inlet tube orifice is covered with a non-woven welded sheet that is welded or bonded to the central body. The inlet orifice may also have a small diameter end that is directed into the container and has a larger cross section than the outlet tube.

  For the purpose of avoiding complications, details regarding the above-described conventional aspects of the present invention have been omitted. This is because such details are known in the above-mentioned patent document. The permanent joint between the annular member and the sheet material constituting the bag 11 and the snap-fit of the central member or the actual nozzle 15 to this are described in the above mentioned Argentine patent application 35,471. It is preferable to have the same characteristics as those shown in FIG.

  According to one aspect of the present invention, a cap 31 is attached to the connector member 15 by two connected flexible strips 41 by molding. The cap 39 has an elongated shape in the same lateral direction as the above-described rear side portion 31 of the wing 23 of the connector 15 together with an internal protrusion 43 that fits into the open portion 29 of the tube. Thus, as will be readily understood, the cap 39 is folded over the outer portion 31 of the connector 15, so that the strip 41 is folded, thereby attaching the strip to the end of the wing 23, and the protrusion 43. It snaps into the open channel 29 enough to seal the open channel 29, and sealing is ensured by ultrasonic or laser welding.

  In the illustrated example, the wing 23 has a span of 87.3 mm so as to correspond to a length of 78.0 mm between the center point of the mounting hole and the connecting portion 27. The width of the open channel 29 is 4.1 mm, and the thickness of the cap 39 is 1.0 mm, just like the protrusion 43 provided on the inner side of the cap 39. The strip 41 for attaching the cap to the connector main body 15 has a length of 3.0 mm, a width of 2.0 mm, and a thickness of 0.8 mm.

  FIG. 4 shows a hole 27 through which the channel 29 of the connector 15 leads, and FIG. 5 shows a reinforcing structure 45 that helps stiffen the connector. Once the bag 11 with the connector central member 15 and the annular member 17 with the cap 39 already welded as described above is made, the powdered product is packed into the bag 11. Next, the actual connector member 15 is placed on the annular member 17 by first introducing a suction tube 35 serving as an extension of the solution outlet so that the filter 37 reaches the bottom of the bag 11. Deploy. Both holes 27 are sealed as shown in FIGS. 6 and 7 by a polyester-coated sheet 47 as shown in FIG. 8 (which is joined by a release hot melt) and then dissolved. A filled and sealed device containing the substance to be stored is ready for transport to a point of use, ie a hospital, clinical center or dialysis center. The annular member 17 is a sealing mounting and holding member provided on the central member of the connector 15 with two purposes or functions: the function as an inlet port for the solid to be melted and the properties of the finished plug. It is understood to perform the function as

  In use, after the release sheet 47 is lifted from the hole 27, the instrument is quickly attached to the dialysis instrument and plugged into the dialysis instrument mounting console, after which the dialysis instrument is connected to the tube 25 to dissolve solids. Pure water or distilled water is pumped through one of them. Such solids, after contact with water, result in a solution containing solids, which can pass through the sieve 37 and thus suck this solution through the tube 35 and dialyze through the outlet tube 21. It can be transported into the instrument, thereby purifying blood taken from the patient to be detoxified and returned by extracorporeal circulation in the case of hemodialysis. When the product in the instrument bag is reduced, the connecting hole 27 is removed, and the instrument is disposed or replaced to perform a new process with a new instrument.

  It will be apparent that various modifications and additions can be made to the embodiments disclosed herein as long as the various modifications and additions are consistent with the spirit and scope of the present invention. For example, while the present invention has been described with respect to a replaceable instrument suitable for a hemodialysis instrument, the provided solution will ultimately be applied to other medical applications that have similar problems to be solved, such as peritoneal dialysis instruments. It should be clear that it can be used. Moreover, although the disclosed embodiment uses a bag, it should be clear that the technical idea of the present invention can be applied to containers in general, independent of the flexibility of the wall of the container.

Claims (16)

  A connector for a replaceable container with a wall, said container having a member with an opening provided in one of said walls, said container being used in a medical instrument The connector has at least a main body, and an inlet pipe and an outlet pipe are provided across the inner part of the main body, and the inlet pipe and the outlet pipe are provided in the connector. When the connector is attached to the container by joining a central member to the member with the opening, the central member extends from the central member toward the outer side of the connector, and the inlet pipe and the outlet pipe are separately provided. A connector extending into two laterally spaced holes, wherein the holes can be removably coupled to attachment means and complementary connections of the medical instrument.   The outer portion has a cap, the cap being initially open to expose a portion of each of the tubes that the cap extends parallel to or along the edge of the outer portion of the connector; The cap is foldable along the link device by a flexible or hinged or fragile link device until the cap covers the initially exposed portion of the tube. The connector of claim 1, wherein the connector is coupled to the connector body.   The connector according to claim 2, wherein the main body, the cap, and the link device are molded into a single piece of synthetic material.   4. A connector according to claim 2 or 3, wherein the linking device comprises two spaced apart flexible strips that attach the same edge of the cap to the corresponding edge of the connector body.   The connector according to claim 2, wherein the cap has an elongated shape, and the link device is attached to a longer edge of the cap.   The cap is a flat member having an inner portion with a protrusion that matches the open length of the tube so that the cap can fit into the tube and seal the tube. The connector according to any one of 5.   The connector according to claim 2, wherein the main body and the cap are molded as separate members made of a synthetic material.   The connector according to claim 1, wherein the two removably attachable holes are sealed by a peeling means.   The connector according to claim 1, wherein the member having the opening and the central member have an annular shape.   The said center member is a connector as described in any one of Claims 1-9 which has an annular rib so that it may snap-fit with the said member provided with the said opening part.   A replaceable disposable container sealed by the connector according to any one of claims 1-10.   The replaceable disposable container of claim 11, wherein the container contains a powdered or granular compound that can be used to make a dialysis solution. 11. A method of manufacturing a container according to any one of claims 1 to 10, wherein a body having an inlet pipe and an outlet pipe extending across the inside from the inner part of the container to the outer part of the connector is formed. And wherein the inlet tube and the outlet tube separately extend in parallel to or along the outer edge of the connector into two removably attachable holes. In the main body, by molding,
a) an opening provided on the outer side to expose the open portions of both the tubes;
b) a cap that conforms to the opening and is attached to the body by a flexible, hinged or fragile link device, the cap until the cap covers the exposed portion of the tube A method adapted to be foldable along a device.   The method of manufacturing a connector according to claim 13, wherein the cap is formed as a separate member.   The method for manufacturing a connector according to claim 13 or 14, wherein the two holes are sealed by a release sheet. A method for producing a replaceable device containing a powder, granule, or similar substance to be attached to a medical instrument for preparing a medical solution, in particular a dialysis solution, comprising:
a) preparing a device having two members, wherein one of the members is a container having a member having an opening, and the other member is any one of claims 1 to 10. A connector according to claim 1,
b) filling the container by introducing solids into the container through the opening;
c) fitting the connector into the opening of the member of the container so that the connector and the member are in a sealed fit relationship.

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